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510(k) K172028

Device
Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray And Medium Spray)
Applicant
Gebauer Company
510(k) number
K172028
Product code
MLY  
Decision
Substantially Equivalent (SESE)
Decision date
2017-10-27
Date received
2017-07-05
Regulation
510(k) Premarket Notification
Classification name
Refrigerant, Topical (vapocoolant)
Medical specialty
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
Review panel
Physical Medicine
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Brittney Schmies
Address
4444 E. 153rd St. Cleveland OH US 44128 44128

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MLY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K243654DentalJectVapocoolshot, Inc.2025-05-30
K232674PainFreeze IINuance Medical, LLC2024-02-12
K203661CRYO Arctic, CRYO PenguinCryoscience North America, Inc.2022-05-25
K202782num Vapocoolant623 Medical, LLC2020-12-21
K201248Syringe Holder accessoryVapocoolshot, Inc.2020-08-12
K193349Vapocoolshot MistVapocoolshot, Inc.2020-04-14
K190161Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint spray, Ethyl Chloride Mist, Ethyl Chloride Accustream 360* Medium Spray, Ethyl Chloride Accustream 360* Fine SprayGebauer Company2019-05-07
K172598Coventry Topical Anesthetic Mist Spray HAZMAT FREE, Coventry Topical Anesthetic Stream Spray HAZMAT FREEItw Contamination Control Electronics2018-04-19
K172203CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream SprayNuance Medical, LLC2017-10-18
K162218Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102Nuance Medical, LLC2016-11-22
K093951OUCHLESS MODEL PN10114Occam Design2010-06-15
K033720ARI COLD SPRAYAri2005-06-10
K032671GEBAUER'S SKIN REFRIGERANT (MIST STREAM), GEBAUER'S SKIN REFRIGERANT (STREAM SPRAY), MODELS P/N 0386-0010-07Gebauer Co.2004-03-17
K030281CRYOTRON 2 CRYOTHERAPY DEVICECryonic Medical North America2003-08-20
K031036GEBAUER'S SKIN REFRIGERANT (MIST SPRAY), MODEL P/N 0386-0010-07, GEBAUER'S SKIN REFRIGERENT (MEDIUM SPRAY), MODEL P/N-03Gebauer Co.2003-07-10

Legacy Summary#

summary

FDA Review#

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